Tuesday, December 16, 2008

Current Psychiatry: Guess the CME Sponsor!

Today, we have a special treat for you, a supplement from Current Psychiatry, entitled “Diagnosing and Managing Psychotic and Mood Disorders.” It is accessible online here.

The rules of this game are simple: No peeking to see which drug company has paid for the preparation of the supplement (so skip page 2).

Let’s start, shall we?

This supplement is composed of four case studies. As we know from past experience, medical education communication companies (MECCs) increasingly use case studies to communicate a marketing message in CME. Medscape did this so blatantly once that BusinessWeek published an article about it.Both Medscape and Dowden Health Media (publisher of Current Psychiatry) love to use cases because they offer so many avenues for promoting the sponsor’s drug. There are usually three phases of promotion:

Phase 1: The case begins with a patient doing poorly on medications. This “bad” medication regimen is strategically chosen by the MECC to cast competitors in a poor light.

Phase 2: The “faculty” members (most or all of whom are consultants or speakers for the sponsoring drug company) then discuss the case, ostensibly in order to come up with ideas for how to improve the patient’s treatment. Here, the MECC can choose to highlight themes to accentuate advantages of the sponsor’s drug and shortcomings of competitors.

Phase 3: Finally, there is a dramatic denouement, in which the faculty decides on a better medication regimen. Obviously, MECCs will ensure that the rescue regimen incorporates the sponsor’s drug. If they are good at gaming this system, they will try not to make this blatantly obvious. As we’ll see below, Dowden Health Media has a lot to learn about subtlety.

2. Faculty discussion:--Is the patient’s diagnosis of schizophrenia accurate? The faculty decides that the patient may actually have either schizoaffective disorder or bipolar disorder.--They discuss the bad side effects of first generation antipsychotics, such as EPS.

Comment: Janssen’s Risperdal Consta jumps out at us, because the rescue regimen involves increasing the dose as well as starting clozapine. However, it would be hard to imagine Janssen being happy about a case in which a patient starts by doing poorly on their medication. The faculty dwells on disadvantages of older antipsychotics, seemingly in order to lay the groundwork for the promotion of one of the atypicals, but at this point, we don’t know which one they will favor. Clozapine is available as a generic, so is not sponsorable. At this point, the only thing we can be fairly certain of is that Janssen is not the sponsor of the supplement.

Case 2: Psychosis with bipolar mania

1. Initial unsuccessful regimen: Risperdal and valproic acid; Risperdal was stopped because it wasn’t working, the patient was switched to Zyprexa, which helped a bit but caused 18 pounds of weight gain in one month.

2. Faculty discussion:--The patient was initially misdiagnosed with ADHD and depression, but actually had bipolar disorder; initial use of stimulants may have precipitated a manic episode. (The message here is: “Diagnose more bipolar disorder.” This is a common industry CME tactic, in which experts harp on how the diagnosis for which the sponsor makes a drug is often missed. After all, the sponsor can’t make money unless the condition is liberally diagnosed.)--Zyprexa is bad. To quote Dr. Pariser: “Olanzapine is a very effective atypical antipsychotic, but weight gain is a major concern for many patients receiving this drug as well as clozapine. I have observed that many patients who gain weight tend to go off the medication, and those who do may not always admit that they are nonadherent.”

3. Rescue regimen: Lamictal, topiramate, and an un-named medication that Dr. Goldberg coyly describes in these terms: “another atypical antipsychotic with a somewhat lower risk of metabolic side effects, relative to olanzapine, as well as an indication for treating bipolar depression to help lower the risk of suicide in this high-risk patient.” Which medication might Dr. Goldberg be referring to? Well, there are only two FDA-approved medications for bipolar depression: Symbyax (Zyprexa combined with Prozac), and Seroquel. Since he specifies that the best choice would not be Zyprexa, he must be referring to Seroquel.

Comment: The sponsor sure ain’t Eli Lilly. Any MECC that would take CME money from Lilly and then feature a case in which Zyprexa caused an astonishing 18 pounds of weight gain in one month would never see another dime from Lilly again.

While lamotrigine and topiramate were part of the rescue regimen, they are both generic, so unsponsorable. The rescue antipsychotic was Seroquel, so after two cases, my best guess is that the sponsor is AstraZeneca, maker of Seroquel.

Case 3: Bipolar depression and anxiety

1. Initial unsuccessful regimen: Effexor XR and clonazepam

2. Faculty discussion:--Patient was misdiagnosed with depression; actually had bipolar disorder and OCD (diagnose more bipolar!)--It can be difficult treating bipolar disorder when combined with anxiety. But Seroquel may actually be a good choice for both! To quote Dr. Goldberg: “Given data from studies of generalized anxiety disorder and quetiapine’s ability to reduce anxiety symptoms in the context of depression, using this drug alone might be safer than augmenting with sertraline and be just as effective as the combination.”3. Rescue regimen: Seroquel, lamotrigine, and sertraline.

Comment: Looks like the MECC is pushing Seroquel for anxiety in anticipation of a possible indication for generalized anxiety disorder. Both lamotrigine and sertraline are generic and unsponsorable.

2. Faculty discussion:--Yet another patient with bipolar disorder misdiagnosed with depression—I guess there’s an epidemic of this. Funny how the faculty neglects to cover the evidence indicating that bipolar disorder may now be over-diagnosed.

3. Rescue regimen: Seroquel and lamotrigine.

Comment: C’mon guys, Seroquel again? Would it kill you to be subtle?

Conclusion

Let’s go through the possible sponsors.

Janssen: No, because Invega was not mentioned, and in one case, Risperdal Consta was ineffective at the starting dose.

Eli Lilly: No, because Zyprexa was never used as a rescue medication, and one of the cases featured the worst example of Zyprexa-induced weight gain that I have heard of.

Pfizer: No, because Geodon is never a used as a rescue medication.

Bristol-Myers Squibb: No, because Abilify is hardly mentioned at all.

My guess is that the sponsor is AstraZeneca, because in three out of the four cases, Seroquel is the linchpin of the rescue regimen.

Now for the fun part. Go back to the supplement, turn to page 2, and you’ll find that the sponsor is………AstraZeneca, maker of Seroquel.

Winners receive a lifetime supply of Seroquel. We are not responsible for fatalities, injuries, or loss of employment due to the sedation and weight gain caused by Seroquel. Employees of AstraZeneca and Dowden Health Media are not eligible for participation in this contest.

21 comments:

therapyfirst
said...

It is nice of you to present this despicable supplement as you do, but let's be as candid and blunt as possible: Current Psychiatry, with it's pharma lackey Dr Nasrallah, is such a shill for pushing meds overall, with its pharma ads right in the middle of articles, I find it beyond annoying.

I will give this publication some credit, as there is an article in this month's issue that talks about the role of placebo and other non-pharmacological impacts on meds having effect, that they do mention other interventions besides meds. But COME ON, ads every four to six pages in the middle of articles, with these ridiculous 3 to 4 pages of PDR supplement crap we can read if needed in our own PDRs or other Meds guides MDs can access?

Thank you for noting this bs though. Again, it will take people of proper influence and respect to shame these frauds of alleged neutrality out into the open.

"Ignore that shameless MD with pharma bucks spilling out of his pockets behind the curtain!"

He ain't a wizard, just a sideshow charlatan out to potentially separate you from your health, except his crystal ball is instead unsubstantiated pills.

The road to hell is paved with good intentions. An adage that should be above every MDs' door.

>Therapyfirst: There is a lot of ads in the American Journal, but the AJP is not industry-sponsored (OK, they are not in the middle of articles, but..).It is sometimes hard to guess if the journal is or is not industry-devoted !

TF: You have the clinical data for each case. Give us your treatment plan. These are ordinary patients. Here is your chance to teach good psychiatry. Nothing in your personal attacks on doctors is of any use to such patients.

Another winner, Dr. Carlat! This parlor game is not only great fun, it is edifying in the way it requires integrated thought about illness, diagnostic labelling, awareness of biases of omission and comission, etc.

On a related topic, is there a movement afoot to protest the ascension of APA President-Elect Schatzberg? His presidency would add to the distrust psychiatrists must already contend with, in terms of conflicts of interest and undisclosed industry sponsorship. I've seen nothing but formulaic comments from the APA, and suspect the Board is myopic on this issue.

Great article, as usual. So where is the actual CME sponsor for this (the one accredited to provide CME)? The University of Cincinnati is ultimately responsible for ensuring that this activity meets all essentials and standards--regardless of whether there is an MECC or equivalent in the middle.

Danny, you should send this to the ACCME complaint department. Maybe, after all the attention from the Senate Finance Committee, press, and others, the ACCME is actually going to make an effort to identify and address these violations?

Are you all really this innocent and naive?!?! Of course the content is biased to the sponsoring company, anybody past the third year of medical school knows this. Here is a suggestion (and it is what I do with all supplements) throw them away unopened, that way you will not offend your delicate sensibilities with industry sponsored message. Any CME program announcement the first place to look is at the bottom to see who is sponsoring and you will know what the message will be. Drug companies try to expand market share, it s what they do. I suppose you were all shocked to find gambling in the back room as well....

Supremacy Claus challenges therapyfirst to offer alternative treatment plans, but that isn't the point. Most pharm promotion isn't conducted by spouting untruths or poor clinical choices. It's the biased choice of which truths to present. For every case where Seroquel is a legitimate rescue drug, there's another where it's the "bad" drug at the beginning of the case. As Dan shows, the bias in the cases chosen is obvious enough to guess the sponsor. That's a pretty good test of whether the content is biased.

I agree with Anonymous though: Best to toss such supplements rather than waste too much time analyzing them. I wish more MDs did that.

It's easy to know that it was AstraZeneca. In every single case, these are approved FDA indications for Seroquel or soon to be approved FDA indications for Seroquel. Also, doctors Nasrallah, Muzina and Goldberg are Seroquel speakers. When I teach my residents psychopharmacology, "guessing the CME sponsor" is part of my curriculum.

The most recent anonymous posting somewhat bothers me, because I read it to note that pharma sponsorship is still tolerated as much as used as fun in an educated forum.

Make no mistake about it, in my humble but experienced position, anything that still validates a role of pharma in education is wrong, and isn't that the point this blog author is trying to impress upon reasonable and fair clinicians? And why aren't more readers, if they see the falsehood to the push for antipsychotics for other non-psychotic indications, saying so much. I have been advocating we as a group reject this disgusting notion that Seroquel should be considered an anxiolytic fairly much since I started commenting at this blog back in feb 08, and yet I read little to none echoing this concern.

Silence leads to death, folks. Don't take my word for it, just look at the history of professions and groups being scared or stupidly reticent to take a stand.

Look at what other sites are saying about the arrogance, that will be the final nail in the coffin of this profession, that is paving the path DSM V is being fostered on us.

If you are a clinician and you really give a damn about psychiatry, or about mental health in general at least, speak up and stand up to the bastards who are only looking out for themselves and opening their own golden parachutes while we who are interested in practicing another 20 or more years crash and burn.

Is it me, or isn't it more than coincidence a lot of the jerks who Grassley is exposing are people who are at the end of their careers. Yeah, the people I want to look up to as mentors or leaders. NOT! And I think someone else at a different posting asked what the APA will do with Schatzberg's pending term as President. Don't expect a majority of members to actually take a stand, because if they did, they wouldn't have voted this judas a leader in the first place.

Just remember, Harold Eist only won by 4% points back in 1995 when he ran an anti-managed care platform against Steven Sharfstein's unsaid "it's here to stay, deal with it" position. That spoke what is the mindset of too many of my colleagues 13 years ago, and all most of them have done is age and be more inflexible. Yeah, I'm pissed, and responsibility and integrity sure aren't traits you'll see in many MDs these days, until proven otherwise.

Maybe people should be somewhat forced to retire after 65. Sorry if that offends some, but the behaviors I see in older colleagues offends me.

Happy holidays. Spin the dreidel with this lame crowd of Grassleys, and see nothing but nun's (a hanukah reference, not christian).

therapyfirst

PS: supremacy claus, don't ask me to respond to your baiting, I am not interested to be batman to your joker intentions.

I don't know, do you think that opiates should be FDA approved for migraines as a first line agent?

Or, perhaps we as physicians should be advising patients to start using antibiotics as preemptive measures when people work in environments that have extensive exposure to others?

What is your point? Atypical antipsychotics, or what I feel is a better term, novel antipsychotics, are being fostered on an unsuspecting public for so many non-psychotic indications that there will eventually be a push for an indication outside psychiatric needs. Oh, I forgot, Lilly pushed for an indication for Zyprexa for migraines about 5 years ago. Wow, what a tie in to my initial sarcastic example in the beginning of this comment!

So, JP, a little transparency on your part, you have an interest in the use of antipsychotics or anticonvulsants that goes beyond just belittling me?

Serendipitous examples have their place in medicine, but they should not be used as cause for over-indications for applications.

And yes, there is a place for anticonvulsants in psychiatry. But, are you willing to explain how Neurontin was oversold, or perhaps how Topamax still is pushed as a weight loss agent when their trials for an indication were pulled after side effect profiles were seen as fairly hideous in a quantifiable size in the trials?

The better and more accurate term for these medications is the elegant "tranquilizers." They quiet the brain when it goes off without a good environmental reason, as in, yes, voices, delusions, but also allergies (the first use), tics, nausea, fear, anger, sadness, hiccups, cravings for addictive substances and activities.

Their potential has yet to be fully explored by the desperate clinician facing the desperate patient, and not by the paper shuffler in an Ivy shop.

For once, I agree with Supremacy Claus's above comment. We are in a time and place of desperation, as physicians are desparate to maintain an income, and patients are desparate to find a quick fix for problems that have almost always festered for years.

It doesn't mean it is right or should be accepted as status quo.

Notice at the bottom of the cliffs there is no one alive to say, "oops, I shouldn't have followed that lead!"

TF: Sorry to disagree on the rare occasion you agree. The doc is not personally desperate. The doc is doing great. The doc is desperate to help the non-responder, and has to create a remedy that does not exist. This doc needs as many tools as possible to score a victory on behalf of the desperate patient.

The left, the lawyer, the insurance company, and their doctor running dogs are totally threatening to this clinician's ability to create.

The history of psychiatry and neurology is filled with medications used for an initial purpose that later were serendipidously found to have additional properties -- beta-blockers for tremor; MAOIs for depression; SSRIs or TCAs for anxiety; SGAs for tics; some anticonvulsants for neuropathic pain. A small number of anticonvulsants have mood value, and most don't, at least based on controlled trials. They also differ in their anti-epilepsy properties (carb, for example, is much more effective for complex partial seizures than GTC seizures). The field may be guilty of globbing on to a hoped-for indication based on a hoped-for class effect (e.g., all anticonvulsants for mood disorder; all anti-hypertensives for tremor; all types of analgesics for all types of pain, whether neuropathic or osteoarthritic or otherwise) -- but till rigorous studies are done we can't know what is or isn't evidence-based. Parke-Davis' legal shame was promoting Neurontin for off-label use; their ethical shame was doing so before the negative randomized trials emerged. There's plenty of negative published data out there -- if practitioners rely on Pharma to educate us rather than the primary literature, the knowledge is selective and the shame falls on us.

Per your above Jan 11 comment, there is nothing to differ on, but the comment is generic to me.

Again, as per the point to this posting by Dr Carlat, do you generally have no qualm with antipsychotics being considered for multiple indications outside psychosis, and to a limited degree with mania? I do, and I think as this matter goes unchallenged by the majority of psychiatrists, these drugs will be a sizeable nail in the coffin to psychiatry's demise if the applications are not challenged.

Your point specifically with this drug class?

And, by the way, as people minimize/legitimize what Pfizer and the prior company that started Neurontin (Roche, I think) tried to pull with promotions, it only paves the way for further efforts by other companies, if the consequence was basically just a slap on the wrist.

Re. JP: If shoe polish were incontrovertably shown to treat an ailment that the WHO ranked as the 6th leading cause of disability, for which 1 in 5 afflicted individuals suicided, and for which few reliable alternative treatments existed, I would be remiss as a physician to ignore the evidence, regardless of my personal feelings about shoe polish or its manufacturer(s). Seems to me our job is to know about and inform our patients about what works and what doesn't, unbiased by our sentiments about a manufacturer, and then to judge the risks and benefits relative to other viable effective treatments (same as oncologists must with antineoplastics, or internists must with coumadin [rat poison] or digoxin). STEP-BD, STAR*D and CATIE show us just how limited our options are. My point, specifically, with this drug class is that at least some of its members work for ailments that precious few alternative treatments also work. Ragging on the product manufacturers is a distraction from our own obligation to weigh the merits of the science.

Great post, I couldn't agree more with antipsychotics being used, at least a little too enthusiastically. I don't know if the subject of adult ADHD has been discussed in this blog before, but I do notice I get a lot of case reports supporting adult ADHD treatment and the CME support does often come from Shire or similiar.